This alternative standard was approved on June 22, 1999 and was made retroactive to April 28, 1999. It has no time limit.

The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(5)(xi) states that:

(xi) Decompression. If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, the system shall be tested to confirm that it provides:

(A) An override capability to allow maintenance of compression;

(B) A continuous display of the override status; and

(C) A manual emergency compression release that can be activated in the event of power or automatic release failure.

The approved alternative standard to 21 CFR 900.12(e)(5)(xi)(B) allows facilities having machines equipped with automatic decompression devices that are never disabled to permanently place a label on the panel indicating that the unit must always be operated in the automatic decompression mode, in lieu of a continuous display of the automatic decompression override status required in 21 CFR 900.12(e)(5)(xi)(B). The wording of this label must be:

"Unit always to be used in auto release mode. If auto release is overridden this status will not be displayed."

 

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